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Manufacturing Nutritional Supplements - General Info

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Science-Based Product Formulation

NAI scientifically designs and customizes nutritional products based on the unique needs of individual clients. New products and formulas are researched and tested prior to full-scale production. NAI continuously produces pilot or sample runs of product formulation prototypes to ensure stability and/or efficacy and to determine ingredient interaction and prospective customer acceptance of the final product. The company also directs and participates in clinical research studies to establish consumer benefits and scientific efficacy supporting both product claims and marketing initiatives.

NAI's team of scientists utilizes the verified results of these clinical studies to design customized nutritional products. NAI has performed numerous clinical investigations in affiliation with renowned universities and research institutions, both in the United States and internationally. The study results are presented at various scientific meetings and symposia and are published in numerous peer reviewed scientific journals. The science behind our formulations ensures that our customers receive the most advanced nutritional supplements available.

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Raw Material Acquisition and Analysis

The manufacturing process begins when NAI receives a formal copy of the customer's purchase order. The order is entered into a state-of-the-art BAAN computer system, which manages all aspects of production scheduling, raw material delivery, packaging coordination, and shipment tracking. A printout is generated specifying which raw materials are needed to complete the order. Raw material vendors are then contacted. NAI has agents searching for raw materials in locations around the globe. NAI uses only the finest materials available. Materials are kept in quarantine and rigorously tested to ensure quality, purity and potency.

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Production

In September 1999, NAI opened a new facility in Vista, California for materials receiving, warehousing, weighing and blending and distribution. The facility consolidates these operations into one location to improve materials and inventory management, work-in-process manufacturing, product distribution, as well as overall manufacturing and quality process controls. Quantities of each material are weighed out according to specifications outlined in the batch record, verified by a second party and are then assigned to a designated blender.

Raw materials are added to the blender in sequence and rotated according to a prescribed mixing time. Formulations are assayed by batch, ensuring the potency and purity of every product we manufacture. The blended material is then encapsulated or compressed into solid dosage forms of either chewable wafers or tablets, producing capsules, tablets or caplets that adhere to exacting standards.

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Testing and Quality Assurance

Our onsite laboratory continuously monitors the output of the production facility to ensure the highest quality of finished goods. We conduct extensive laboratory testing on state-of-the-art laboratory equipment including High Performance Liquid Chromatography (HPLC), Inductively Coupled Plasma Emission Spectrophotometry (ICP), Dissolution and Absorption, Microbiological Testing, and Fourier Transform Near Infrared Spectroscopy (FT-NIR). All products are meticulously examined for weight, ingredient homogeneity, color standardization and content levels. Tablets are tested for hardness, thickness, dissolution and integrity. This extensive laboratory testing ensures that NAI's customers are supplied with products that conform to the highest standards.

NAI certifies that each raw material used meets or exceeds the requirements upheld by the U.S. Food and Drug Administration (FDA), the U.S. Pharmacopoeia (USP) and the Therapeutic Goods Administration of Australia (TGA). Raw materials are also tested to ensure that they are free of harmful pesticides and herbicides and have no trace of heavy metal contamination. NAI maintains a Retention Room where samples of product, Certificates of Analysis and identification of vendors and lot numbers for raw materials are stored for a minimum of five years. This enables the Company to trace the source of every element of every product.

NAI maintains compliance with both USP and Good Manufacturing Practices (GMP) for Food, Drugs and Cosmetics, which are used internationally to ensure that products manufactured under these strict guidelines fulfill required standards of quality for nutraceutical products. NAI's quality control is part of every step of its manufacturing and procurement processes.

In October 1999, NAI received certification and approval from the prestigious Therapeutic Goods Administration of Australia (TGA) for its encapsulating and tableting operations. In March 2000 the Company was re-certified in all areas including its new packaging operations. The TGA is a Division of the Federal Department of Health and Aged Care and is responsible for administering the provisions of the Therapeutic Goods Act. The TGA evaluates new therapeutic products, prepares standards, develops testing methods and conducts testing programs to ensure products are high quality, safe and effective. TGA certification also enables the Company to manufacture products for export into countries which have signed the Pharmaceutical Inspection Convention and includes most European countries as well as several Pacific Rim countries. The TGA's goal is to protect public health by ensuring that products meet definable standards of quality assurance and are manufactured in conditions that are clean and free of contaminants. These stringent standards ensure standardized quality in all products manufactured by NAI.

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Packaging

Once encapsulation and tableting are completed, finished products are assigned to a packaging line. In April 2000, NAI began operating its own finished goods packaging facility in Vista, CA. This new capability substantially eliminates the need to use outside packaging services to produce finished goods. NAI's packaging capabilities include bottles, powder fill, blister cards and packets. Management believes the ability to offer in-house packaging will help control costs and improve inventory management/quality control. As an example, product components are checked for lot identification, quality and adherence to specifications both prior to and during the packaging process. Tamper-evident safety seals are applied to each bottle to ensure the integrity of the product.

After packaging is completed, the finished product is palleted, labeled and prepared for shipment. NAI's Graphic Design team works with each customer to create labels that have aesthetic appeal and adhere to Dietary Supplement Health and Education Act (DSHEA) guidelines for consumer labeling set forth by the U.S. Food & Drug Administration.

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Marketing Support

NAI's marketing and product development experts are accomplished in the areas of market research, supplement design, manufacturing, packaging, distribution, international product registration and regulatory compliance. The Company provides in-house graphic design capabilities and works with clients to create label designs, brochures, videos and other promotional tools to appropriately market its products. The combination of these components is part of a cohesive strategy designed to increase mass-market consciousness, boost brand awareness among the health-conscious consumers and facilitate expansion into new markets and channels of distribution.

As part of its marketing strategy, NAI works with nationally recognized physicians to both increase our understanding of the ever-changing marketplace and to develop branded products that reflect unique approaches to restoring, maintaining or improving health.

NAI's success in the formulation, development, manufacturing and marketing of specialized products is predicated on its dedication to research and development, technology, science and state-of-the-art manufacturing. The comprehensive services NAI offers has established NAI as an innovator in the field of nutritional science.

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© Copyright 1999-2017, Natural Alternatives International, Inc.

        

    

Natural Alternatives International, Inc. (NAI) is a leading formulator and manufacturer of customized nutritional supplements. Contract manufacturing GMP TGA USP Swissmedic NSF Sport San Marcos NAII Vista California Switzerland Japan Australia blended blender capsule certification compliance international laboratory NAI nutritional purity quality regulatory research scientific standards state-of-the-art supplement tablet